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In response to the COVID-19 pandemic, we rapidly implemented a plasma coordination center, within two months, to support transfusion for two outpatient randomized controlled trials. The center design was based on an investigational drug services model and a Food and Drug Administration-compliant database to manage blood product inventory and trial safety.
Methods:
A core investigational team adapted a cloud-based platform to randomize patient assignments and track inventory distribution of control plasma and high-titer COVID-19 convalescent plasma of different blood groups from 29 donor collection centers directly to blood banks serving 26 transfusion sites.
Results:
We performed 1,351 transfusions in 16 months. The transparency of the digital inventory at each site was critical to facilitate qualification, randomization, and overnight shipments of blood group-compatible plasma for transfusions into trial participants. While inventory challenges were heightened with COVID-19 convalescent plasma, the cloud-based system, and the flexible approach of the plasma coordination center staff across the blood bank network enabled decentralized procurement and distribution of investigational products to maintain inventory thresholds and overcome local supply chain restraints at the sites.
Conclusion:
The rapid creation of a plasma coordination center for outpatient transfusions is infrequent in the academic setting. Distributing more than 3,100 plasma units to blood banks charged with managing investigational inventory across the U.S. in a decentralized manner posed operational and regulatory challenges while providing opportunities for the plasma coordination center to contribute to research of global importance. This program can serve as a template in subsequent public health emergencies.
In the works of controversy that poured from the presses in the century after the Reformation in England, religious opponents regularly called each other by the names of animals. Biblical animals were favored by both puritans and conformists in the early Tudor era, as controversialists sought to claim for their own words the authority of scripture. The metaphoric animals employed by Elizabethan controversialists were more varied, derived from biblical, classical, and some popular sources. By the mid-seventeenth century, the rhetorical animals evoked by religious controversialists were drawn from a wide range of mostly secular sources and were notable for figuring predatory violence, monstrosity, and grotesqueness. Everyday experience of animals was kept strictly separate from the roles that they were assigned in polemical tracts. Arguably, the extreme animalizing of opponents contributed to the failure of negotiation and compromise as civil war approached.
Improving the quality and conduct of multi-center clinical trials is essential to the generation of generalizable knowledge about the safety and efficacy of healthcare treatments. Despite significant effort and expense, many clinical trials are unsuccessful. The National Center for Advancing Translational Science launched the Trial Innovation Network to address critical roadblocks in multi-center trials by leveraging existing infrastructure and developing operational innovations. We provide an overview of the roadblocks that led to opportunities for operational innovation, our work to develop, define, and map innovations across the network, and how we implemented and disseminated mature innovations.
New technologies and disruptions related to Coronavirus disease-2019 have led to expansion of decentralized approaches to clinical trials. Remote tools and methods hold promise for increasing trial efficiency and reducing burdens and barriers by facilitating participation outside of traditional clinical settings and taking studies directly to participants. The Trial Innovation Network, established in 2016 by the National Center for Advancing Clinical and Translational Science to address critical roadblocks in clinical research and accelerate the translational research process, has consulted on over 400 research study proposals to date. Its recommendations for decentralized approaches have included eConsent, participant-informed study design, remote intervention, study task reminders, social media recruitment, and return of results for participants. Some clinical trial elements have worked well when decentralized, while others, including remote recruitment and patient monitoring, need further refinement and assessment to determine their value. Partially decentralized, or “hybrid” trials, offer a first step to optimizing remote methods. Decentralized processes demonstrate potential to improve urban-rural diversity, but their impact on inclusion of racially and ethnically marginalized populations requires further study. To optimize inclusive participation in decentralized clinical trials, efforts must be made to build trust among marginalized communities, and to ensure access to remote technology.
We summarize what we assess as the past year's most important findings within climate change research: limits to adaptation, vulnerability hotspots, new threats coming from the climate–health nexus, climate (im)mobility and security, sustainable practices for land use and finance, losses and damages, inclusive societal climate decisions and ways to overcome structural barriers to accelerate mitigation and limit global warming to below 2°C.
Technical summary
We synthesize 10 topics within climate research where there have been significant advances or emerging scientific consensus since January 2021. The selection of these insights was based on input from an international open call with broad disciplinary scope. Findings concern: (1) new aspects of soft and hard limits to adaptation; (2) the emergence of regional vulnerability hotspots from climate impacts and human vulnerability; (3) new threats on the climate–health horizon – some involving plants and animals; (4) climate (im)mobility and the need for anticipatory action; (5) security and climate; (6) sustainable land management as a prerequisite to land-based solutions; (7) sustainable finance practices in the private sector and the need for political guidance; (8) the urgent planetary imperative for addressing losses and damages; (9) inclusive societal choices for climate-resilient development and (10) how to overcome barriers to accelerate mitigation and limit global warming to below 2°C.
Social media summary
Science has evidence on barriers to mitigation and how to overcome them to avoid limits to adaptation across multiple fields.
The Rapid ASKAP Continuum Survey (RACS) is the first large-area survey to be conducted with the full 36-antenna Australian Square Kilometre Array Pathfinder (ASKAP) telescope. RACS will provide a shallow model of the ASKAP sky that will aid the calibration of future deep ASKAP surveys. RACS will cover the whole sky visible from the ASKAP site in Western Australia and will cover the full ASKAP band of 700–1800 MHz. The RACS images are generally deeper than the existing NRAO VLA Sky Survey and Sydney University Molonglo Sky Survey radio surveys and have better spatial resolution. All RACS survey products will be public, including radio images (with
$\sim$
15 arcsec resolution) and catalogues of about three million source components with spectral index and polarisation information. In this paper, we present a description of the RACS survey and the first data release of 903 images covering the sky south of declination
$+41^\circ$
made over a 288-MHz band centred at 887.5 MHz.
Weed seedbanks have been studied intensively at local scales, but to date, there have been no regional-scale studies of weed seedbank persistence. Empirical and modeling studies indicate that reducing weed seedbank persistence can play an important role in integrated weed management. Annual seedbank persistence of 13 summer annual weed species was studied from 2001 through 2003 at eight locations in the north central United States and one location in the northwestern United States. Effects of seed depth placement, tillage, and abiotic environmental factors on seedbank persistence were examined through regression and multivariate ordinations. All species examined showed a negative relationship between hydrothermal time and seedbank persistence. Seedbank persistence was very similar between the two years of the study for common lambsquarters, giant foxtail, and velvetleaf when data were pooled over location, depth, and tillage. Seedbank persistence of common lambsquarters, giant foxtail, and velvetleaf from October 2001 through 2002 and October 2002 through 2003 was, respectively, 52.3% and 60.0%, 21.3% and 21.8%, and 57.5% and 57.2%. These results demonstrate that robust estimates of seedbank persistence are possible when many observations are averaged over numerous locations. Future studies are needed to develop methods of reducing seedbank persistence, especially for weed species with particularly long-lived seeds.
This monograph summarizes the proceedings of a roundtable meeting convened to discuss pseudobulbar affect (PBA). Two didactic lectures were presented, followed by a moderated discussion among 11 participants. Post-meeting manuscript development synthesized didactic- and discussion-based content and incorporated additional material from the neuroscience literature. A conceptual framework with which to distinguish between disorders of mood and affect is presented first, and disorders of affect regulation are then reviewed briefly. A detailed description of the most common of these disorders, PBA, is the focus of the remainder of the monograph. The prevalence, putative neuranatomic and neurochemical bases of PBA are reviewed, and current and emerging methods of evaluation and treatment of persons with PBA are discussed. The material presented in this monograph will help clinicians better recognize, diagnose, and treat PBA, and will form a foundation for understanding and interpreting future studies of this condition.
According to the 2007–2008 National Health and Nutrition Examination Survey, the prevalence of obesity in the US population was 33·8 %; 34·3 % and 38·2 %, respectively, in middle-aged men and women. We asked whether available blood donor data could be used for obesity surveillance.
Design
Cross-sectional study of BMI and obesity, defined as BMI ≥ 30·0 kg/m2. Adjusted odds ratios (aOR) were calculated with logistic regression.
Setting
A network of six US blood centres.
Subjects
Existing data on self-reported height and weight from blood donors, excluding persons deferred for very low body weight.
Results
Among 1 042 817 donors between January 2007 and December 2008, the prevalence of obesity was 25·1 %; 25·7 % in men and 24·4 % in women. Obesity was associated with middle age (age 50–59 years v. <20 years: aOR = 1·92 for men and 1·81 for women), black (aOR = 1·57 for men and 2·35 for women) and Hispanic (aOR = 1·47 for men and 1·49 for women) race/ethnicity compared with white race/ethnicity, and inversely associated with higher educational attainment (college degree v. high school or lower: aOR = 0·56 for men and 0·48 for women) and double red cell donation and platelet donation.
Conclusions
Obesity is common among US blood donors, although of modestly lower prevalence than in the general population, and is associated with recognized demographic factors. Blood donors with higher BMI are specifically recruited for certain blood collection procedures. Blood centres can play a public health role in obesity surveillance and interventions.
Division III, with 1126 members, is the third largest of the 12 IAU Divisions, focusing on subject matter related to the physical study of interplanetary dust, comets, minor planets, satellites, planets, planetary systems and astrobiology. Within the Division are very active working groups that are responsible for planetary system and small body nomenclature, as well as a newly created working group on Near Earth Objects which was established order to investigate the requirements for international ground-and/or space-based NEO surveys to characterize 90% of all NEOs with diameters >40m in order to establish a permanent international NEO Early Warning System.
The CSBN meeting held in Rio de Janeiro on August 11 was attended by just six members, including Pam Kilmartin as the acting chair, and several visitors. Since there was not a quorum of members, it was not possible to make any decisions. But there was a good discussion on many topics, from which several points emerged that should be more fully discussed by the whole committee during the next few months:
The meeting was opened by Ted Bowell, president, at 11 am. The 2006 Division III meetings were reviewed by Guy Consolmagno, secretary; as the minutes of those meetings have already been published, they were assumed to be approved.